TI
MES Change Specialist
Tranzeal Inc.
- 🇺🇸 United States
- On-site
- 14 hours ago
- Change Management
- Veeva
- Technical Writing
- Regulatory Compliance
- SAP
- PLC
- HMI
- Shopify Liquid
14 hours ago
Location: Hillsboro, OR (No Relocations)
Duration: 8+ months (Extensions possible)
Must have experience working in a manufacturing environment
Description:
The Opportunity:
- As part of the Process and Compliance Team in manufacturing, you will perform a wide variety of tasks and operations that are required to design, build, test, validate, and maintain pharmaceutical production in a state-of-the-art, highly-automated production and packaging facility. The MES Change Specialist works cross-functionally with manufacturing, P&C, ITOT, Master data, and many other departments to ensure the efficient construction and effective functionality of our electronic documentation for operations across HTO.
- In addition to performing the responsibilities/tasks below, the successful candidate will need to demonstrate the following traits and capabilities:
- You will troubleshoot and identify resolutions for mechanical or automation related failures in production
- You will identify opportunities to improve leveraging data analytics of system performance to deliver reduced costs and increased efficiency.
- You will lead user requirement gathering for operational needs and perform initial requirement assessments for MES modifications
- You will own CSV functions including defining requirements, writing and execution of test scripts
- Translate operational requirements into recipe and workflow requirements that will define CSV test protocols
- Development, authoring, and executing of protocols for configuration verification (CV) and functional verification (FV) testing of MES recipes and workflows according to approved procedures and CSV principles
- Investigate and assess exceptions and deviations from CV and FV protocol testing
- You will own plan, execute, and improve review of MES changes for a set of assigned manufacturing processes driven by the change management process, including testing and implementation
- You will monitor project schedule and escalate concerns to leadership with appropriate time to mitigate
- You will assist with drafting test plans for MES changes, including comprehensive test plans and/or reports for new recipes
- You will own MES-related deviations, including high-complexity or multi-site deviations relating to MES defects. Ensure corrective actions resolve issues effectively
- You will support MES-components of other site initiatives, including capitalized projects, tech transfers, Drug Substance/Drug Product (DS/DP) changes, shutdown projects, and new launches
- You will serve as an audit support for MES, providing demonstrations, presentations, and answering questions as required. If topical, support closure of any MES-related regulatory findings.
Who you are:
- You hold a Bachelor's degree in a relevant field plus 3-5 years of MES, electronic batch record, or computerized systems experience for regulated manufacturing OR Master's degree in a relevant field
- You have prior experience with construction, testing, and validation of computerized systems
- You have extensive prior experience working in electronic change management systems (trackwise, Veeva, etc.) to own changes and coordinate action items spanning multiple departments
- Prior experience in IT, OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP), preferably in a regulated industry.
- You have a strong understanding of test requirements for electronic data systems for regulatory compliance
- You have knowledge of the automation systems that include SAP, Manufacturing Execution Systems (MES), Programmable Logic Controllers (PLC) and Human Machine Interfaces (HMI)
- You have prior experience with sterile pharmaceutical manufacturing (solution prep, equipment prep, liquid/lyo vial filling, PFS, formulation, inspection, packaging, etc)
- Ownership of changes in a change management system (ex. Veeva) from initiation to closure
- You have experience with troubleshooting Rockwell systems, including remote or on-site support, is strongly preferred
- It is preferred you have prior experience on an EBR or MES deployment projects.
MES Change Specialist · Tranzeal Inc.